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    <tradeName>PRLS 2NDMOL B/T 12DEG -10T 018 WDX UR</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -10T 018 WDX UR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>517-2204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:41.467Z</lastUpdated>
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    <udiDi>00889989054200</udiDi>
    <basicUdiDi>B-00889989054200</basicUdiDi>
    <tradeName>PRLS 2NDMOL B/T 12DEG -10T 022 WDX UR</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -10T 022 WDX UR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>517-2203</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:40.666Z</lastUpdated>
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    <udiDi>00889989054194</udiDi>
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    <tradeName>PRLS 2NDMOL B/T 12DEG -27T 018 NDX LR</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -27T 018 NDX LR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>517-2108</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:39.878Z</lastUpdated>
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    <udiDi>00889989054187</udiDi>
    <basicUdiDi>B-00889989054187</basicUdiDi>
    <tradeName>PRLS 2NDMOL B/T 12DEG -27T 022 NDX LR</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -27T 022 NDX LR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>517-2107</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:35.857Z</lastUpdated>
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    <udiDi>00889989054170</udiDi>
    <basicUdiDi>B-00889989054170</basicUdiDi>
    <tradeName>PRLS 2NDMOL B/T 12DEG -10T 018 NDX UR</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -10T 018 NDX UR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>517-2104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:35.063Z</lastUpdated>
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    <udiDi>00889989054163</udiDi>
    <basicUdiDi>B-00889989054163</basicUdiDi>
    <tradeName>PRLS 2NDMOL B/T 12DEG -10T 022 NDX UR</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -10T 022 NDX UR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>517-2103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:34.255Z</lastUpdated>
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    <udiDi>00889989054156</udiDi>
    <basicUdiDi>B-00889989054156</basicUdiDi>
    <tradeName>PRLS 2NDMOL B/T 12DEG -27T 018 WDX LL</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -27T 018 WDX LL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>516-2208</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:33.452Z</lastUpdated>
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    <udiDi>00889989054149</udiDi>
    <basicUdiDi>B-00889989054149</basicUdiDi>
    <tradeName>PRLS 2NDMOL B/T 12DEG -10T 018 WDX UL</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -10T 018 WDX UL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>516-2204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:29.446Z</lastUpdated>
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    <udiDi>00889989054132</udiDi>
    <basicUdiDi>B-00889989054132</basicUdiDi>
    <tradeName>PRLS 2NDMOL B/T 12DEG -10T 022 WDX UL</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -10T 022 WDX UL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>516-2203</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:28.743Z</lastUpdated>
  </row>
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    <udiDi>00889989054125</udiDi>
    <basicUdiDi>B-00889989054125</basicUdiDi>
    <tradeName>PRLS 2NDMOL B/T 12DEG -27T 018 NDX LL</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -27T 018 NDX LL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>516-2108</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:27.056Z</lastUpdated>
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    <udiDi>00889989054118</udiDi>
    <basicUdiDi>B-00889989054118</basicUdiDi>
    <tradeName>PRLS 2NDMOL B/T 12DEG -27T 022 NDX LL</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -27T 022 NDX LL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>516-2107</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:26.266Z</lastUpdated>
  </row>
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    <udiDi>00889989054101</udiDi>
    <basicUdiDi>B-00889989054101</basicUdiDi>
    <tradeName>PRLS 2NDMOL B/T 12DEG -10T 018 NDX UL</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -10T 018 NDX UL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>516-2104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:22.244Z</lastUpdated>
  </row>
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    <udiDi>00889989054095</udiDi>
    <basicUdiDi>B-00889989054095</basicUdiDi>
    <tradeName>PRLS 2NDMOL B/T 12DEG -10T 022 NDX UL</tradeName>
    <deviceName>PRLS 2NDMOL B/T 12DEG -10T 022 NDX UL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>516-2103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:21.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054088</udiDi>
    <basicUdiDi>B-00889989054088</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S WDX -27TX18 LL</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S WDX -27TX18 LL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>515-0232</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:20.653Z</lastUpdated>
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    <udiDi>00889989054071</udiDi>
    <basicUdiDi>B-00889989054071</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S WDX -27TX22 LL</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S WDX -27TX22 LL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>515-0231</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:19.846Z</lastUpdated>
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    <udiDi>00889989054064</udiDi>
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    <tradeName>ORTHOS ACCENT USM 15SGL WDX -10TX18 L</tradeName>
    <deviceName>ORTHOS ACCENT USM 15SGL WDX -10TX18 L</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>515-0216</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:15.056Z</lastUpdated>
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    <udiDi>00889989054057</udiDi>
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    <tradeName>ORTHOS ACCENT USM 15SGL WDX -10TX22 L</tradeName>
    <deviceName>ORTHOS ACCENT USM 15SGL WDX -10TX22 L</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>515-0215</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:14.256Z</lastUpdated>
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    <udiDi>00889989054040</udiDi>
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    <tradeName>ORTHOS ACCENT LSM 5SGL WDX -10TX18 R</tradeName>
    <deviceName>ORTHOS ACCENT LSM 5SGL WDX -10TX18 R</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>515-0214</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:13.465Z</lastUpdated>
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    <udiDi>00889989054033</udiDi>
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    <tradeName>ORTHOS ACCENT LSM 5SGL WDX -10TX22 R</tradeName>
    <deviceName>ORTHOS ACCENT LSM 5SGL WDX -10TX22 R</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>515-0213</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:12.648Z</lastUpdated>
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    <udiDi>00889989054026</udiDi>
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    <tradeName>ACCENT B/T 5SGL 2ND WDX -10TX18 UL</tradeName>
    <deviceName>ACCENT B/T 5SGL 2ND WDX -10TX18 UL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>515-0212</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:07.839Z</lastUpdated>
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